Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Barnstead/Thermolyne Corp. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K014174 | HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST1273 | Barnstead/Thermolyne Corp. | 2002-02-22 | 64 | 0 |
| K953938 | STERILEMAX | Barnstead/Thermolyne Corp. | 1997-01-30 | 528 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda